BNF for Children (BNFC) 2018-2019

Medicines for Children leaflet: Ursodeoxycholic acid for cholestasis

and sclerosing cholangitiswww.medicinesforchildren.org.uk/

ursodeoxycholic-acid-for-cholestasis-and-sclerosing-cholangitis

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug. Forms available from special-order

manufacturers include: oral suspension, oral solution

Oral suspension

CAUTIONARY AND ADVISORY LABELS 21

▶Ursofalk(Dr. Falk Pharma UK Ltd)

Ursodeoxycholic acid 50 mg per 1 mlUrsofalk 250 mg/ 5 ml oral

suspension sugar-free| 250 mlP£ 26. 98 DT = £ 26. 98

Tablet

CAUTIONARY AND ADVISORY LABELS 21

▶Ursodeoxycholic acid (Non-proprietary)

Ursodeoxycholic acid 150 mgUrsodeoxycholic acid 150 mg tablets

| 60 tabletP£ 19. 02 DT = £ 19. 02

Ursodeoxycholic acid 300 mgUrsodeoxycholic acid 300 mg tablets

| 60 tabletP£ 47. 63 DT = £ 47. 63

▶Cholurso(HFA Healthcare Products Ltd)

Ursodeoxycholic acid 250 mgCholurso 250 mg tablets|

60 tabletP£ 15. 49 DT = £ 15. 49

Ursodeoxycholic acid 500 mgCholurso 500 mg tablets|

60 tabletP£ 45. 00

▶Destolit(Norgine Pharmaceuticals Ltd)

Ursodeoxycholic acid 150 mgDestolit 150 mg tablets|

60 tabletP£ 18. 39 DT = £ 19. 02

▶Ursofalk(Dr. Falk Pharma UK Ltd)

Ursodeoxycholic acid 500 mgUrsofalk 500 mg tablets|

100 tabletP£ 80. 00 DT = £ 80. 00

Capsule

CAUTIONARY AND ADVISORY LABELS 21

▶Ursodeoxycholic acid (Non-proprietary)

Ursodeoxycholic acid 250 mgUrsodeoxycholic acid 250 mg capsules

| 60 capsuleP£ 31. 50 DT = £ 15. 75 | 100 capsuleP£ 26. 25

▶Ursofalk(Dr. Falk Pharma UK Ltd)

Ursodeoxycholic acid 250 mgUrsofalk 250 mg capsules|

60 capsuleP£ 30. 17 DT = £ 15. 75 | 100 capsuleP£ 31. 88

LIPIDS›STEROLS

Cholesterol

lINDICATIONS AND DOSE

Smith-Lemli-Opitz syndrome

▶BY MOUTH

▶Neonate: 5 – 10 mg/kg 3 – 4 times a day.

▶Child: 5 – 10 mg/kg 3 – 4 times a day, doses up to

15 mg/kg 4 times daily have been used

lUNLICENSED USENot licensed.

lCONTRA-INDICATIONS

CONTRA-INDICATIONS, FURTHER INFORMATION

For contra-indications, consult product literature.

lCAUTIONS

CAUTIONS, FURTHER INFORMATIONFor advice on cautions,

consult product literature.

lDIRECTIONS FOR ADMINISTRATIONCholesterol powder can

be mixed with a vegetable oil before administration.

lMEDICINAL FORMS

Forms available from special-order manufacturers include: oral

suspension, powder

7.2 Oesophageal varices

PITUITARY AND HYPOTHALAMIC HORMONES

AND ANALOGUES›VASOPRESSIN AND

ANALOGUES

Terlipressin acetate

lINDICATIONS AND DOSE

GLYPRESSIN®INJECTION

Adjunct in acute massive haemorrhage of gastro-

intestinal tract or oesophageal varices (specialist use

only)

▶BY INTRAVENOUS INJECTION

▶Child 12–17 years (body-weight up to 50 kg):Initially 2 mg

every 4 hours until bleeding controlled, then reduced

to 1 mg every 4 hours if required, maximum duration

48 hours

▶Child 12–17 years (body-weight 50 kg and above):Initially

2 mg every 4 hours until bleeding controlled, reduced if

not tolerated to 1 mg every 4 hours, maximum duration

48 hours

VARIQUEL®INJECTION

Adjunct in acute massive haemorrhage of gastro-

intestinal tract or oesophageal varices (specialist use

only)

▶BY INTRAVENOUS INJECTION

▶Child 12–17 years (body-weight up to 50 kg):Initially 1 mg,

then 1 mg every 4 – 6 hours for up to 72 hours, to be

administered over 1 minute

▶Child 12–17 years (body-weight 50–69 kg):Initially 1. 5 mg,

then 1 mg every 4 – 6 hours for up to 72 hours, to be

administered over 1 minute

▶Child 12–17 years (body-weight 70 kg and above):Initially

2 mg, then 1 mg every 4 – 6 hours for up to 72 hours, to

be administered over 1 minute

lUNLICENSED USEUnlicensed for use in children.

lCAUTIONSArrhythmia.electrolyte andfluid disturbances.

heart disease.history of QT-interval prolongation.

respiratory disease.septic shock.uncontrolled

hypertension.vascular disease

lSIDE-EFFECTS

▶Common or very commonAbdominal cramps.arrhythmias

.diarrhoea.headache.hypertension.hypotension.pallor

.peripheral ischaemia.vasoconstriction

▶UncommonChest pain.cyanosis.fluid overload.heart

failure.hotflush.hyponatraemia.intestinal ischaemia.

ischaemic heart disease.lymphangitis.myocardial

infarction.nausea.pulmonary oedema.respiratory

disorders.seizure.skin necrosis.uterine disorders.

vomiting

▶Rare or very rareDyspnoea.hyperglycaemia.stroke

lPREGNANCYAvoid unless benefits outweigh risk—uterine

contractions and increased intra-uterine pressure in early

pregnancy, and decreased uterine bloodflow reported.

lBREAST FEEDINGAvoid unless benefits outweigh risk—no

information available.

lRENAL IMPAIRMENTUse with caution in chronic renal

failure.

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Solution for injection

▶Glypressin(Ferring Pharmaceuticals Ltd)

Terlipressin acetate 120 microgram per 1 mlGlypressin 1 mg/ 8. 5 ml

solution for injection ampoules| 5 ampoulePs

66 Liver disorders and related conditions BNFC 2018 – 2019

Gastro-intestinal system

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